Apellis, Sobi present data from open-label period of Phase 3 VALIANT study

Apellis Pharmaceuticals (APLS) and Sobi (BIOVF) presented new data from the open-label period of the Phase 3 VALIANT study, investigating EMPAVELI for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis. The data were presented as part of a late-breaking session at the European Renal Association Congress. In the VALIANT study, EMPAVELI demonstrated a statistically significant 68% proteinuria reduction versus placebo at Week 26, which was sustained at one year. Additionally, patients treated with EMPAVELI continued to achieve stabilization of kidney function as measured by estimated glomerular filtration rate. “The one-year Phase 3 results are very compelling, confirming EMPAVELI’s sustained benefits across key markers of disease,” said Fadi Fakhouri, presenting author, co-lead principal investigator for the VALIANT study, and professor of nephrology at CHUV Lausanne. “Given the high risk of kidney failure, treatment efficacy is incredibly important to C3G and primary IC-MPGN patients, many of whom are in the prime of their lives. These data further underscore the potential of EMPAVELI to make a meaningful difference for patients.” In patients who switched from placebo to EMPAVELI at the start of the open-label period, EMPAVELI demonstrated a similar magnitude of benefit in proteinuria reduction and stabilization of kidney function. EMPAVELI showed favorable safety and tolerability, consistent with its established profile. There were no new safety signals.